Senate Bill No. 158 CHAPTER 294 An act to amend Sections 1288.5 and 1288.8 of, and to add Sections 1279.6, 1279.7, 1288.45 and 1288.95 to, the Health and Safety Code, relating to health facilities. [Approved by Governor September 25, 2008. Filed with Secretary of State September 25, 2008.] legislative counsel s digest SB 158, Florez. Hospitals: patient safety and infection control. Existing law provides for the licensure and regulation by the State Department of Public Health of health facilities, including general acute care hospitals, acute psychiatric hospitals, and special hospitals, as defined. A violation of these provisions is a crime. This bill would require health facilities, as defined, to develop, implement, and comply with a patient safety plan for the purpose of improving the health and safety of patients and reducing preventable patient safety events. The bill would require the patient safety plan to establish a patient safety committee composed of health care professionals, and to contain other prescribed elements. This bill would also require health facilities, as defined, to implement a facility wide hand hygiene program and, beginning January 1, 2011, would prohibit the use of intravenous, epidural, or enteral feeding connections that would fit into a connection port other than the type it was intended for, unless an emergency or urgent situation exists and the prohibition impairs the ability to provide health care. Existing law establishes the Hospital Infectious Disease Control Program, which, among other things, requires the department and general acute care hospitals to implement various measures relating to disease surveillance and the prevention of health-care-associated infection (HAI). In that regard, the department is required, by July 1, 2007, to appoint a Healthcare Associated Infection Advisory Committee (HAI-AC), composed of specified members, to make recommendations related to methods of reporting cases of hospital acquired infections occurring in general acute care hospitals, as provided. Existing law also requires each general acute care hospital, in collaboration with infection prevention and control professionals, and with the participation of senior health care facility leadership, as a component of its strategic plan, at least once every 3 years, to prepare a written report that examines the hospital s existing resources and evaluates the quality and effectiveness of the hospital s infection surveillance and prevention program, including specified information.
2 This bill would establish a health care infection surveillance, prevention, and control program within the department and require the department, the HAI-AC, and general acute care hospitals, as defined, to take specified actions to implement the program. This bill would also require, no later than January 1, 2010, specified training for a physician designated as the hospital epidemiologist or infection surveillance, prevention, and control committee chairperson. Also, beginning in January 2010, the bill would require prescribed training for other hospital staff, as specified. By changing the definition of an existing crime, this bill would impose a state-mandated local program. The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement. This bill would provide that no reimbursement is required by this act for a specified reason. The people of the State of California do enact as follows: SECTION 1. (a) The Legislature finds and declares all of the following: (1) During the past two decades, health-care-associated infections (HAI), especially those that are resistant to commonly used antibiotics, have increased dramatically in California. (2) There is currently no system within the State Department of Public Health to determine the incidence or prevalence of HAI or to determine if current infection prevention and control measures are effective in reducing HAI. (3) A significant percentage of HAI can be prevented with intense programs for surveillance and the development, implementation, and constant evaluation and monitoring of prevention strategies. (4) There is currently inadequate regulatory oversight of hospital surveillance, prevention, and control programs by the department. (5) The protection of patients in a general acute care hospital is of paramount importance to the citizens of California. (6) Existing state law requires the department to establish and maintain an inspection and reporting system to ensure that general acute care hospitals are in compliance with state statutes and regulations. Existing law also requires general acute care hospitals receiving funding from the federal Centers for Medicare and Medicaid Services to be in compliance with the federal regulations known as the conditions of participation. (b) It is the intent of the Legislature to enact legislation to ensure the occurrence of all of the following: (1) Establishment of an infection surveillance, prevention, and control program within the State Department of Public Health. (2) Dissemination of current evidence-based standards of hospital infection surveillance, prevention, and control practices.
3 (3) Improvement of regulatory oversight. (4) Reports of the incidence rate of designated HAI are made to the department, and as applicable, to the National Healthcare Safety Network (NHSN) of the federal Centers for Disease Control and Prevention. (5) Development and implementation of an Internet-based public reporting system on HAI. (6) Maintenance of a sanitary environment and patient hygiene to avoid transmission of pathogens that cause HAI. SEC. 2. Section 1279.6 is added to the Health and Safety Code, to read: 1279.6. (a) A health facility, as defined in subdivision (a), (b), (c), or (f) of Section 1250, shall develop, implement, and comply with a patient safety plan for the purpose of improving the health and safety of patients and reducing preventable patient safety events. The patient safety plan shall be developed by the facility, in consultation with the facility s various health care professionals. (b) The patient safety plan required pursuant to subdivision (a) shall, at a minimum, provide for the establishment of all of the following: (1) A patient safety committee or equivalent committee in composition and function. The committee shall be composed of the facility s various health care professionals, including, but not limited to, physicians, nurses, pharmacists, and administrators. The committee shall do all of the following: (A) Review and approve the patient safety plan. (B) Receive and review reports of patient safety events as defined in subdivision (c). (C) Monitor implementation of corrective actions for patient safety events. (D) Make recommendations to eliminate future patient safety events. (E) Review and revise the patient safety plan, at least once a year, but more often if necessary, to evaluate and update the plan, and to incorporate advancements in patient safety practices. (2) A reporting system for patient safety events that allows anyone involved, including, but not limited to, health care practitioners, facility employees, patients, and visitors, to make a report of a patient safety event to the health facility. (3) A process for a team of facility staff to conduct analyses, including, but not limited to, root cause analyses of patient safety events. The team shall be composed of the facility s various categories of health care professionals, with the appropriate competencies to conduct the required analyses. (4) A reporting process that supports and encourages a culture of safety and reporting patient safety events. (5) A process for providing ongoing patient safety training for facility personnel and health care practitioners. (c) For the purposes of this section, patient safety events shall be defined by the patient safety plan and shall include, but not be limited to, all adverse events or potential adverse events as described in Section 1279.1 that are determined to be preventable, and health-care-associated infections (HAI), as defined in the federal Centers for Disease Control and Prevention s
4 National Healthcare Safety Network, or its successor, unless the department accepts the recommendation of the Healthcare Associated Infection Advisory Committee, or its successor, that are determined to be preventable. SEC. 3. Section 1279.7 is added to the Health and Safety Code, to read: 1279.7. (a) A health facility, as defined in subdivision (a), (b), (c), or (f) of Section 1250, shall implement a facility-wide hand hygiene program. (b) Beginning January 1, 2011, a health facility, as defined in subdivision (a), (b), (c), or (f) of Section 1250, is prohibited from using an intravenous connection, epidural connection, or enteral feeding connection that would fit into a connection port other than the type it was intended for, unless an emergency or urgent situation exists and the prohibition impairs the ability to provide health care. SEC. 4. Section 1288.45 is added to the Health and Safety Code, to begin Article 3.5 of Chapter 2 of Division 2, to read: 1288.45. For purposes of this article, the following definitions shall apply: (a) Advisory committee or HAI-AC means the Healthcare Associated Infection Advisory Committee established pursuant to Section 1288.5. (b) Health-care-associated infection, health facility acquired infection, or HAI means an infection defined by the National Health and Safety Network of the federal Centers for Disease Control and Prevention, unless the department adopts a definition consistent with the recommendations of the advisory committee or its successor. (c) Hospital means a general acute care hospital as defined pursuant to subdivision (a) of Section 1250. (d) Infection prevention professional means a registered nurse, medical technologist, or other salaried employee or consultant who, within two years of appointment, will meet the education and experience requirements for certification established by the national Certification Board for Infection Control and Epidemiology (CBIC), but does not include a physician who is appointed or receives a stipend as the infection prevention and control committee chairperson or hospital epidemiologist. (e) MRSA means methicillin-resistant Staphylococcus aureus. (f) National Healthcare Safety Network or NHSN means a secure, Internet-based system developed and managed by the federal Centers for Disease Control and Prevention (CDC) to collect, analyze, and report risk-adjusted HAI data related to the incidence of HAI and the process measures implemented to prevent these infections. (g) Program means the health care infection surveillance, prevention, and control program within the department. SEC. 5. Section 1288.5 of the Health and Safety Code is amended to read: 1288.5. (a) By July 1, 2007, the department shall appoint a Healthcare Associated Infection Advisory Committee (HAI-AC) that shall make recommendations related to methods of reporting cases of hospital acquired infections occurring in general acute care hospitals, and shall make recommendations on the use of national guidelines and the public reporting
5 of process measures for preventing the spread of HAI that are reported to the department pursuant to subdivision (b) of Section 1288.8. (b) The advisory committee shall include persons with expertise in the surveillance, prevention, and control of hospital-acquired infections, including department staff, local health department officials, health care infection control professionals, hospital administration professionals, health care providers, health care consumers, physicians with expertise in infectious disease and hospital epidemiology, and integrated health care systems experts or representatives. (c) The advisory committee shall meet at least every quarter and shall serve without compensation, but shall be reimbursed for travel-related expenses that include transportation, lodging, and meals at the state per diem reimbursement rate. (d) In addition to the responsibilities enumerated in subdivision (a), the advisory committee shall do all of the following: (1) Review and evaluate federal and state legislation, regulations, and accreditation standards and communicate to the department how hospital infection prevention and control programs will be impacted. (2) In accordance with subdivision (a) of Section 1288.6, recommend a method by which the number of infection prevention professionals would be assessed in each hospital. (3) Recommend an educational curriculum by which health facility evaluator nurses and department consultants would be trained to survey for hospital infection surveillance, prevention, and control programs. (4) Recommend a method by which hospitals are audited to determine the validity and reliability of data submitted to the NHSN and the department. (5) Recommend a standardized method by which an HAI occurring after hospital discharge would be identified. (6) Recommend a method by which risk-adjusted HAI data would be reported to the public, the Legislature, and the Governor. (7) Recommend a standardized method by which department health facility evaluator nurses and consultants would evaluate health care workers for compliance with infection prevention procedures including, but not limited to, hand hygiene and environmental sanitation procedures. (8) Recommend a method by which all hospital infection prevention professionals would be trained to use the NHSN HAI surveillance reporting system. SEC. 6. Section 1288.8 of the Health and Safety Code is amended to read: 1288.8. (a) By January 1, 2008, the department shall take all of the following actions to protect against HAI in general acute care hospitals statewide: (1) Implement an HAI surveillance and prevention program designed to assess the department s resource needs, educate health facility evaluator nurses in HAI, and educate department staff on methods of implementing recommendations for disease prevention.
6 (2) Revise existing and adopt new administrative regulations, as necessary, to incorporate current federal Centers for Disease Control and Prevention (CDC) guidelines and standards for HAI prevention. (3) Require that general acute care hospitals develop a process for evaluating the judicious use of antibiotics, the results of which shall be monitored jointly by appropriate representatives and committees involved in quality improvement activities. (b) On and after January 1, 2008, each general acute care hospital shall implement and annually report to the department on its implementation of infection surveillance and infection prevention process measures that have been recommended by the federal Centers for Disease Control and Prevention Healthcare Infection Control Practices Advisory Committee, as suitable for a mandatory public reporting program. Initially, these process measures shall include the CDC guidelines for central line insertion practices, surgical antimicrobial prophylaxis, and influenza vaccination of patients and healthcare personnel. In consultation with the advisory committee, the department shall make this information public no later than six months after receiving the data. (c) The advisory committee shall make recommendations for phasing in the implementation and public reporting of additional process measures and outcome measures by January 1, 2008, and, in doing so, shall consider the measures recommended by the CDC. (d) Each general acute care hospital shall also submit data on implemented process measures to the National Healthcare Safety Network of the CDC, or to any other scientifically valid national HAI reporting system based upon the recommendation of the federal Centers for Disease Control and Prevention Healthcare Infection Control Practices Advisory Committee or to another scientifically valid reporting database, as determined by the department based on the recommendations of the HAI-AC. Hospitals shall utilize the federal Centers for Disease Control and Prevention definitions and methodology for surveillance of HAI. Hospitals participating in the California Hospital Assessment and Reporting Task Force (CHART) shall publicly report those HAI measures as agreed to by all CHART hospitals. (e) In addition to the requirements in subdivision (a), the department shall establish an infection surveillance, prevention, and control program to do all of the following: (1) Designate infection prevention professionals to serve as consultants to the licensing and certification program. (2) Provide education and training to department health facility evaluator nurses and consultants to effectively survey hospitals for compliance with infection surveillance, prevention, and control recommendations, as well as state and federal statutes and regulations. (3) By January 1, 2011, in consultation with the HAI-AC, develop a scientifically valid statewide electronic reporting system or utilize an existing scientifically valid database system capable of receiving electronically transmitted reports from hospitals related to HAI.
7 (4) Provide current infection prevention and control information to the public on the Internet. (5) Beginning January 1, 2011, provide to the Governor, the Legislature, and the Chairs of the Senate Committee on Health and Assembly Committee on Health, and post on the department s Web site, an annual report of publicly reported HAI infection information received and reported pursuant to this article. SEC. 7. Section 1288.95 is added to the Health and Safety Code, to read: 1288.95. (a) No later than January 1, 2010, a physician designated as a hospital epidemiologist or infection surveillance, prevention, and control committee chairperson shall participate in a continuing medical education (CME) training program offered by the federal Centers for Disease Control and Prevention (CDC) and the Society for Healthcare Epidemiologists of America, or other recognized professional organization. The CME program shall be specific to infection surveillance, prevention, and control. Documentation of attendance shall be placed in the physician s credentialing file. (b) Beginning January 2010, all staff and contract physicians and all other licensed independent contractors, including, but not limited to, nurse practitioners and physician assistants, shall be trained in methods to prevent transmission of HAI, including, but not limited to, MRSA and Clostridium difficile infection. (c) By January 2010, all permanent and temporary hospital employees and contractual staff, including students, shall be trained in hospital-specific infection prevention and control policies, including, but not limited to, hand hygiene, facility-specific isolation procedures, patient hygiene, and environmental sanitation procedures. The training shall be given annually and when new policies have been adopted by the infection surveillance, prevention, and control committee. (d) Environmental services staff shall be trained by the hospital and shall be observed for compliance with hospital sanitation measures. The training shall be given at the start of employment, when new prevention measures have been adopted, and annually thereafter. Cultures of the environment may be randomly obtained by the hospital to determine compliance with hospital sanitation procedures. SEC. 8. No reimbursement is required by this act pursuant to Section 6 of Article XIII B of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIII B of the California Constitution. O